Baxter SIGMA Spectrum Infusion Pump with Master Drug Library, Model #/Product Code 35700BAX2
- Company
- Baxter Healthcare Corporation
- Recall Initiated
- January 26, 2017
- Terminated
- May 24, 2018
- Recall Number
- Z-1693-2017
- Quantity
- Domestic: 14,175 units; Canada: 187 units
- Firm Location
- Medina, NY
Reason for Recall
SIGMA Spectrum Infusion Pumps with Master Drug Library, Software V8.00.02 contains an anomaly that may cause a Sharp Watchdog Timeout error message. Specifically, the software anomaly causes the error message only under conditions in which a message is being written to the Spectrum Infusion Pumps Event History Log (EHL), and the length of that message exactly matches the size of the available memory at the end of a memory sector. For this reason, the issue is significantly more likely to manifest when poor network maintenance results in high volumes of messages being written to the EHL.
Distribution
Natiowide, Puerto Rico and Canada
Lot / Code Info
14,362 Serial Numbers (please contact CDRH for list of affected Serial Numbers).
Root Cause
Process design
Action Taken
URGENT MEDICAL DEVICE CORRECTION Letters and Reply Forms (dated 1/26/2017) were mailed to customers via USPS first-class mail on 1/26/2017 providing the necessary instructions to customers. For questions, please contact your Baxter sales representative, or Baxter Healthcare Medina at 800-356-3454 (choose option 1) Monday through Friday, between 7:00 am and 7:00 pm ET.